RECRUITING

Supporting Treatment Access and Recovery in COD

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Conditions

Opioid Use DisorderMental Health Disordermental health

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.

Official Title

Supporting Treatment Access and Recovery in Co-Occurring Opioid Use and Mental Health Disorders

Quick Facts

Study Start:2022-03-11
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05138614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Are 18 years-old and older;
  2. * Are fluent in English or Spanish;
  3. * Have OUD who (a) are newly admitted into the program with OUD; or (b) who have been active in the program for the treatment of OUD with medications like buprenorphine or naltrexone, but experienced a recent relapse with any substance (e.g., alcohol, cocaine, opioids, or benzodiazepines). This second group is necessary to include because patients who may have been stable for a long period of time may have a relapse and need intensive treatment to help them regain their abstinence and facilitate the path towards recovery. Thus, by taking those newly enrolled and those who were stable on MOUD but had a recent relapse, the second group is clinically similar to the first group and the intervention will be meaningful.;
  4. * Able to provide consent;
  5. * Potentially have a concurrent substance use disorder in addition to opioids; and
  6. * Have a co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and/or schizophrenia, and those who are stable on buprenorphine or naltrexone but have recurrence or worsening at any time of symptoms of any co-occurring mental health disorder (COD) including depression, anxiety, trauma-related disorders, bipolar, and/or schizophrenia, even if the patient has not relapsed. Instability is defined in two ways in the study: (a) a substance use relapse; and (b) recurrence to symptom exacerbation in regard to a subject's mental health disorder(s). If subjects do not meet criteria for "a" (i.e., not having a substance use relapse), but they do meet criteria for "b" (i.e., they do in fact have worsening of mental health symptoms), they are then defined as unstable, and will meet study inclusion criteria.
  1. * Are not fluent in English or Spanish;
  2. * Are acutely psychotic, acutely suicidal with a plan, or homicidal;
  3. * Are incompetent and unable to provide informed consent; and
  4. * Have concurrent severe alcohol use disorder or high dose benzodiazepine needing detoxification. This exclusion factor is based on DSM-5 criteria, and those who are currently drinking or with a history of severe alcohol withdrawal (i.e., alcohol related seizures, and delirium tremens) will also be excluded. High dose benzodiazepine is defined as using Lorazepam equivalent of \> 10 mg/day; Diazepam \> 100 mg/day; Clonazepam 5 mg/ day; Alprazolam 5 mg/day.

Contacts and Locations

Study Contact

David Smelson, PsyD
CONTACT
508-713-5420
David.Smelson@umassmed.edu
Abigail Helm, PhD
CONTACT
413-313-2806
Abigail.Helm@umassmed.edu

Principal Investigator

David Smelson, PsyD
PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester

Study Locations (Sites)

Behavioral Health Network
Holyoke, Massachusetts, 01040
United States
Behavioral Health Network
Orange, Massachusetts, 01364
United States
Behavioral Health Network
Springfield, Massachusetts, 01104
United States
UMass Chan Road to Care Clinic
Worcester, Massachusetts, 01601
United States
SaVida Health
Worcester, Massachusetts, 01605
United States

Collaborators and Investigators

Sponsor: University of Massachusetts, Worcester

  • David Smelson, PsyD, PRINCIPAL_INVESTIGATOR, University of Massachusetts, Worcester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-11
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2022-03-11
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • opioid use disorder
  • mental health

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Mental Health Disorder